Tall oil, reaction products with ethanolamine

Endpoint summary

Additional information

Acute Toxicity

Fish

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203 "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF.

In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EL50 value from either the algal growth inhibition study or the acute toxicity to Daphnia magna study is set as the threshold loading rate and a 'limit test' is conducted at this threshold loading rate. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LL50 is greater than the threshold loading rate. Since the EL50 value obtained for the algal growth inhibition study was > 160 mg/L and the EL50 value obtained for the acute toxicity to Daphnia magna study was > 100 mg/L, the test was conducted at a single loading rate of 100 mg/L WAF to ensure that toxicity was not observed at this loading rate.

Seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of approximately 15 °C under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined at 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Chemical analysis of the test preparations at 0 and 72 hours (fresh media) and 24 and 96 hours (old media) showed measured test concentrations of less than the limit of Quantification (LOQ) of the analytical method, which was determined to be 0.010 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ.

Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.

Daphnia magna

A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202 "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No 440/2008.

Due to the low solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).

Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a Water Accommodated Fraction (WAF) of the test item at a single nominal loading rate of 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The number of immobilised Daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.

Chemical analysis of the test preparations at 0 and 48 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained, which was determined to be 0.0072 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only. 

Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.

Algae

A study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 761/2009.

Due to the low aqueous solubility and complex nature of the test item, a Water Accommodated Fraction (WAF) was prepared.

Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to Water Accomodated Fractions (WAFs) of the test item over a range of nominal loading rates of 10, 20, 40, 80 and 160 mg/L (three replicates per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C. Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group using a Coulter multisizer particle counter.

Analysis of the 160 mg/L loading rate WAF test preparations at 0 and 72 hours showed that measured test concentrations of 0.0074 and 0.0086 mg/L respectively were obtained and indicated that the test item was stable over the test duration.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of Pseudokirchneriella subcapitata to the test item gave EL50 values of greater than 160 mg/L loading rate WAF. The No observed Effect Loading rate was 160 mg/L loading rate WAF.

Inhibition of sewage sludge microorganisms

A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method was designed to be compatible with OECD Guidelines for Testing of Chemicals (2010) No 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)".

Following a preliminary range-finding test, activated sewage sludge was exposed to an aqueous dispersion of the test item t concentrations of 100, 320 and 1000 mg/L (5 replicates) for a period of 3 hours at a temperature of 20 to 21 °C with the addition of a synthetic sewage as a respiratory substitute. The rate of respiration was determined after 3 hours contact time and compared to data for the control and reference item, 3,5 -dichlorophenol.

The effect of the test item on the respiration of activated sewage sludge gave a 3 -hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration after 3 hours exposure was 100 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L. The reference item gave a 3 -hour EC value of 9.7 mg/L with 95 % confidence limits of 8.0 to 12 mg/L.

Chronic toxicity

Fish

No evidence of aquatic toxicity was reported during acute testing involving three trophic levels. As a result, and in accordance with REACH Annex IX, Section 9.1.6, Column 2, the results of the chemical safety assessment give no cause for concern and investigation of the long-term effects of the test substance on fish is not required.

Daphnia magna

No evidence of aquatic toxicity was reported during acute testing involving three trophic levels. As a result, and in accordance with REACH Annex IX, Section 9.1.5, Column 2, the results of the chemical safety assessment give no cause for concern and investigation of the long-term effects of the test substance on Daphnia is not required.